WO2005102271A3 - Pharmaceutical compositions for glucocorticoid replacement therapy - Google Patents

Pharmaceutical compositions for glucocorticoid replacement therapy Download PDF

Info

Publication number
WO2005102271A3
WO2005102271A3 PCT/EP2005/004400 EP2005004400W WO2005102271A3 WO 2005102271 A3 WO2005102271 A3 WO 2005102271A3 EP 2005004400 W EP2005004400 W EP 2005004400W WO 2005102271 A3 WO2005102271 A3 WO 2005102271A3
Authority
WO
Grant status
Application
Patent type
Prior art keywords
glucocorticoids
glucocorticoid
time
part
component
Prior art date
Application number
PCT/EP2005/004400
Other languages
French (fr)
Other versions
WO2005102271A2 (en )
Inventor
Stanko Skrtic
Joergen Johnsson
Hans Lennernaes
Thomas Hedner
Gudmundur Johannsson
Original Assignee
Duocort Ab
Stanko Skrtic
Joergen Johnsson
Hans Lennernaes
Thomas Hedner
Gudmundur Johannsson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers

Abstract

The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereof in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical composition comprises one or more glucocorticoids, wherein a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours, and the amount of the one or more glucocorticoids of the first part, expressed as hydrocortisone equivalents, is in a range of from about 15 to about 50% of the total hydrocortisone equivalents. The invention also relates to a kit comprising a first and a second component, the first component designed to release one or more glucocorticoids substantially immediately and the second component is designed to release one or more glucocorticoids over an extended period of time of at least 8 hours. The invention also relates to a method for treating diseases requiring glucocorticoid treatment such as in subjects having a glucocorticoid deficiency disorder. In another aspect the invention relates to the use of a first and a second amount of one or more glucocorticoids for the preparation of a pharmaceutical composition or kit for the treatment of a glucocorticoid deficiency disorder.
PCT/EP2005/004400 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy WO2005102271A3 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US56420504 true 2004-04-22 2004-04-22
US60/564,205 2004-04-22
SE0401031-0 2004-04-22
SE0401031A SE0401031D0 (en) 2004-04-22 2004-04-22 A new glucocorticoid replacement therapy

Applications Claiming Priority (20)

Application Number Priority Date Filing Date Title
CN 200580011862 CN1942176B (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
MX2013004889A MX344197B (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy.
BRPI0510044A BRPI0510044A (en) 2004-04-22 2005-04-21 A pharmaceutical composition, kit, method for treating a subject, and use of a first and a second amount of one or more glucocorticoids
ME02584B ME02584B (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
EP20050735076 EP1744730B1 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
JP2007508863A JP5149618B2 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
ES05735076T ES2600556T3 (en) 2004-04-22 2005-04-21 Replacement of pharmaceutical compositions for therapy with glucocorticoids
DK05735076T DK1744730T3 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
US11587514 US8425937B2 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
MXPA06012011A MXPA06012011A (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy.
RS55198B1 RS55198B1 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
AU2005235370A AU2005235370B2 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
LT05735076T LT1744730T (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
CA 2564000 CA2564000C (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy
IL17877606A IL178776A (en) 2004-04-22 2006-10-19 Coated tablet dosage form for delivery of glucocorticoid replacement therapy
US13722013 US20130129823A1 (en) 2004-04-22 2012-12-20 Pharmaceutical compositions for glucocorticoid replacement therapy
IL22737513A IL227375A (en) 2004-04-22 2013-07-08 Coated tablet dosage form for delivery of glucocorticoid replacement therapy
US14255332 US20140242167A1 (en) 2004-04-22 2014-04-17 Pharmaceutical compositions for glucocorticoid replacement therapy
HRP20161380T1 HRP20161380T1 (en) 2004-04-22 2016-10-24 Pharmaceutical compositions for glucocorticoid replacement therapy
CY161101091T CY1118275T1 (en) 2004-04-22 2016-10-26 PHARMACEUTICAL COMPOSITIONS to treat glucocorticoid SUBSTITUTION

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13722013 Continuation US20130129823A1 (en) 2004-04-22 2012-12-20 Pharmaceutical compositions for glucocorticoid replacement therapy

Publications (2)

Publication Number Publication Date
WO2005102271A2 true WO2005102271A2 (en) 2005-11-03
WO2005102271A3 true true WO2005102271A3 (en) 2006-08-03

Family

ID=35197481

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/004400 WO2005102271A3 (en) 2004-04-22 2005-04-21 Pharmaceutical compositions for glucocorticoid replacement therapy

Country Status (8)

Country Link
US (3) US8425937B2 (en)
EP (2) EP1744730B1 (en)
JP (2) JP5149618B2 (en)
CN (2) CN103006592B (en)
CA (1) CA2564000C (en)
DK (1) DK1744730T3 (en)
ES (1) ES2600556T3 (en)
WO (1) WO2005102271A3 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007533697A (en) 2004-04-22 2007-11-22 デュオコート エービーDuocort Ab Glucocorticoid pharmaceutical composition for the acute care
FR2926722B1 (en) * 2008-01-25 2010-09-03 Substipharm Dev A pharmaceutical formulation suitable for the preparation of orodispersible tablets prednisolone
CA2757858C (en) * 2009-04-07 2017-03-28 Duocort Pharma Ab Improved glucocorticoid therapy
WO2011144327A1 (en) * 2010-05-20 2011-11-24 Duocort Pharma Ab Posology and administration of glucocorticoid based compositions
GB201119985D0 (en) * 2011-11-19 2012-01-04 Diurnal Ltd Treatment of adrenal insufficiency
GB201202433D0 (en) 2012-02-13 2012-03-28 Diurnal Ltd Controlled drug release
JP2014086673A (en) 2012-10-26 2014-05-12 Mitsubishi Electric Corp Monolithic integrated circuit
JP2016521270A (en) * 2013-04-16 2016-07-21 マレイ・アンド・プール・エンタープライゼズ・リミテッド Sustained release formulations and methods of use thereof of colchicine
GB201308933D0 (en) * 2013-05-17 2013-07-03 Diurnal Ltd Paediatric composition
EP2886108A1 (en) 2013-12-23 2015-06-24 Dr. Falk Pharma Gmbh Optimised pharmaceutical formula for the treatment of inflammatory changes of the esophagus
WO2016160969A1 (en) * 2015-03-30 2016-10-06 Corcept Therapeutics, Inc. Use of glucocorticoid receptor antagonists in combination with glucocorticoids to treat adrenal insufficiency

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1458676A (en) * 1972-12-09 1976-12-15 Hoechst Ag Orally administrable corticosteroid preparations
WO1992011001A1 (en) * 1990-12-19 1992-07-09 Solvay (Societe Anonyme) Oral pharmaceutical composition
EP0745382A1 (en) * 1994-01-31 1996-12-04 Yamanouchi Pharmaceutical Co. Ltd. Intraorally soluble compressed molding and process for producing the same
WO1998048782A1 (en) * 1997-04-29 1998-11-05 Jenapharm Gmbh & Co. Kg Method for producing orally administered, solid pharmaceutical products with controlled release of the active substance
WO2002072033A2 (en) * 2001-03-13 2002-09-19 Penwest Pharmaceuticals Co. Chronotherapeutic dosage forms containing glucocorticosteroid

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5580578A (en) 1992-01-27 1996-12-03 Euro-Celtique, S.A. Controlled release formulations coated with aqueous dispersions of acrylic polymers
US5314697A (en) 1992-10-23 1994-05-24 Schering Corporation Stable extended release oral dosage composition comprising loratadine and pseudoephedrine
US5534263A (en) 1995-02-24 1996-07-09 Alza Corporation Active agent dosage form comprising a matrix and at least two insoluble bands
US5976573A (en) 1996-07-03 1999-11-02 Rorer Pharmaceutical Products Inc. Aqueous-based pharmaceutical composition
US6602521B1 (en) 1998-09-29 2003-08-05 Impax Pharmaceuticals, Inc. Multiplex drug delivery system suitable for oral administration
US6500459B1 (en) 1999-07-21 2002-12-31 Harinderpal Chhabra Controlled onset and sustained release dosage forms and the preparation thereof
US6156743A (en) 1999-10-18 2000-12-05 Whitcomb; John E. Method of decreasing fatigue
EP1392321B1 (en) * 2001-03-15 2010-08-18 Soligenix, Inc. Method of treating inflammatory disorders of the gastrointestinal tract using topical active corticosteroids
GB0119848D0 (en) 2001-08-15 2001-10-10 Univ Sheffield Delayed and sustained drug release
US6682759B2 (en) 2002-02-01 2004-01-27 Depomed, Inc. Manufacture of oral dosage forms delivering both immediate-release and sustained-release drugs
DE60308647T2 (en) 2002-02-07 2007-08-09 Pharmacia Corp. A pharmaceutical dosage form for mucosal administration
GB0400031D0 (en) 2004-01-03 2004-02-04 Univ Sheffield Depression treatment
GB0623740D0 (en) 2006-11-28 2007-01-10 Diurnal Ltd Treatment of disease
CA2757858C (en) 2009-04-07 2017-03-28 Duocort Pharma Ab Improved glucocorticoid therapy
WO2011144327A1 (en) 2010-05-20 2011-11-24 Duocort Pharma Ab Posology and administration of glucocorticoid based compositions

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1458676A (en) * 1972-12-09 1976-12-15 Hoechst Ag Orally administrable corticosteroid preparations
WO1992011001A1 (en) * 1990-12-19 1992-07-09 Solvay (Societe Anonyme) Oral pharmaceutical composition
EP0745382A1 (en) * 1994-01-31 1996-12-04 Yamanouchi Pharmaceutical Co. Ltd. Intraorally soluble compressed molding and process for producing the same
WO1998048782A1 (en) * 1997-04-29 1998-11-05 Jenapharm Gmbh & Co. Kg Method for producing orally administered, solid pharmaceutical products with controlled release of the active substance
WO2002072033A2 (en) * 2001-03-13 2002-09-19 Penwest Pharmaceuticals Co. Chronotherapeutic dosage forms containing glucocorticosteroid

Also Published As

Publication number Publication date Type
JP2012236846A (en) 2012-12-06 application
EP1744730B1 (en) 2016-08-03 grant
US20080187586A1 (en) 2008-08-07 application
CN103006592A (en) 2013-04-03 application
CN1942176A (en) 2007-04-04 application
CA2564000A1 (en) 2005-11-03 application
WO2005102271A2 (en) 2005-11-03 application
CA2564000C (en) 2013-07-02 grant
EP1744730A2 (en) 2007-01-24 application
ES2600556T3 (en) 2017-02-09 grant
DK1744730T3 (en) 2016-08-29 grant
JP5149618B2 (en) 2013-02-20 grant
US8425937B2 (en) 2013-04-23 grant
EP3072507A1 (en) 2016-09-28 application
JP2007533698A (en) 2007-11-22 application
CN103006592B (en) 2016-03-02 grant
CN1942176B (en) 2013-09-18 grant
US20130129823A1 (en) 2013-05-23 application
JP5681679B2 (en) 2015-03-11 grant
US20140242167A1 (en) 2014-08-28 application

Similar Documents

Publication Publication Date Title
Kasperk et al. Androgens directly stimulate proliferation of bone cells in vitro
Kim et al. Treadmill exercise increases cell proliferation without altering of apoptosis in dentate gyrus of Sprague-Dawley rats
Pettway et al. Parathyroid hormone mediates bone growth through the regulation of osteoblast proliferation and differentiation
Kanno et al. Platelet-rich plasma enhances human osteoblast-like cell proliferation and differentiation
Xu et al. Hydrogen sulfide protects MC3T3-E1 osteoblastic cells against H2O2-induced oxidative damage—implications for the treatment of osteoporosis
Vanmierlo et al. Liver X receptor activation restores memory in aged AD mice without reducing amyloid
Walton et al. Glutamate–glutamine cycling in Alzheimer's disease
Wang et al. Secreted frizzled-related protein 1 modulates glucocorticoid attenuation of osteogenic activities and bone mass
Kastarinen et al. Nonpharmacologic Treatment of Hypertension in Primary Health Care
Tang et al. Apelin stimulates proliferation and suppresses apoptosis of mouse osteoblastic cell line MC3T3-E1 via JNK and PI3-K/Akt signaling pathways
Parada et al. The microglial α7-acetylcholine nicotinic receptor is a key element in promoting neuroprotection by inducing heme oxygenase-1 via nuclear factor erythroid-2-related factor 2
Bijvoet et al. Effect of a diphosphonate on para-articular ossification after total hip replacement
Serbest et al. Temporal profiles of cytoskeletal protein loss following traumatic axonal injury in mice
WO2006044505A3 (en) Compounds for nonsense suppression, and methods for their use
Jensen et al. Maxillary sinus floor augmentation with Bio-Oss or Bio-Oss mixed with autogenous bone as graft in animals: a systematic review
Massot et al. Magnetic field desensitizes 5-HT1B receptor in brain: pharmacological and functional studies
Miron et al. The effect of enamel matrix proteins on the spreading, proliferation and differentiation of osteoblasts cultured on titanium surfaces
Golde et al. Decreased iNOS synthesis mediates dexamethasone‐induced protection of neurons from inflammatory injury in vitro
Mandelin et al. Interface tissue fibroblasts from loose total hip replacement prosthesis produce receptor activator of nuclear factor-kappaB ligand, osteoprotegerin, and cathepsin K.
Liu et al. The role of the extracellular signal-related kinase signaling pathway in osteogenic differentiation of human adipose-derived stem cells and in adipogenic transition initiated by dexamethasone
Bolonkin et al. Experimental exophthalmos. Binding of thyrotropin and an exophthalmogenic factor derived from thyrotropin to retro-orbital tissue plasma membranes.
Ladha et al. Conventional and contemporary luting cements: an overview
Correa et al. Sequential exposure to fibroblast growth factors (FGF) 2, 9 and 18 enhances hMSC chondrogenic differentiation
Shapiro et al. The effect of intravenous pamidronate on bone mineral density, bone histomorphometry, and parameters of bone turnover in adults with type IA osteogenesis imperfecta
Acil et al. The cytotoxic effects of three different bisphosphonates in-vitro on human gingival fibroblasts, osteoblasts and osteogenic sarcoma cells

Legal Events

Date Code Title Description
AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KM KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SM SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

121 Ep: the epo has been informed by wipo that ep was designated in this application
DPEN Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed from 20040101)
WWE Wipo information: entry into national phase

Ref document number: PA/a/2006/012011

Country of ref document: MX

WWE Wipo information: entry into national phase

Ref document number: 2564000

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 200580011862.3

Country of ref document: CN

Ref document number: 178776

Country of ref document: IL

WWE Wipo information: entry into national phase

Ref document number: 2007508863

Country of ref document: JP

WWW Wipo information: withdrawn in national office

Ref document number: DE

NENP Non-entry into the national phase in:

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 551337

Country of ref document: NZ

Ref document number: 2005235370

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2005735076

Country of ref document: EP

Ref document number: 200609680

Country of ref document: ZA

Ref document number: 6945/DELNP/2006

Country of ref document: IN

REEP

Ref document number: 2005735076

Country of ref document: EP

ENP Entry into the national phase in:

Ref document number: 2005235370

Country of ref document: AU

Date of ref document: 20050421

Kind code of ref document: A

WWP Wipo information: published in national office

Ref document number: 2005235370

Country of ref document: AU

WWP Wipo information: published in national office

Ref document number: 2005735076

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 11587514

Country of ref document: US

ENP Entry into the national phase in:

Ref document number: PI0510044

Country of ref document: BR

WWE Wipo information: entry into national phase

Ref document number: P-2016/0749

Country of ref document: RS